Radiopharmaceutical Industry Update: Q4/Q1 (2024-2025)

In 2025, the U.S. radiopharmaceutical market is expected to see continued growth, driven by aging populations, advancements in theranostics, an increased demand for targeted cancer treatments and an expansion of applications beyond oncology. North America is projected to dominate the global market. According to Precedence Research, the global radiopharmaceuticals market size was $11.85 billion in 2024, calculated at $13.21 billion in 2025 and is projected to surpass $35.04 billion by 2034, expanding at a compound annual growth rate (CAGR) of 11.45% between 2025 and 2034. Even more bullish, Fortune Business Insights projects 19.9% CAGR, from $11.77 billion in 2025 to $42.03 billion by 2032.

This projected growth has already increased demand for pharma service vendors and supply chains that help mitigate the risk of bottlenecks impacting the timely availability of these critical diagnostic and therapeutic medicines. Key bottleneck areas include manufacturing capacity, stringent regulations, short half-lives of the radiopharmaceuticals, and the need for specialized expertise and infrastructure. Increased consolidation in 2025 is likely, as companies seek to secure supply chains and expertise. Private equity-backed vendors also are likely to play a larger role, leveraging capital to scale operations and meet increasing demand.

The following update provides a snapshot of recent commercial developments in the radiopharmaceutical services industry, with a focus on pharma services, such as contract development and manufacturing organizations (CDMO), contract manufacturing organizations (CMOs) and nuclear pharmacies (radiopharmacies). The update also provides an overview of recent regulatory developments in this space and their anticipated impact, including a discussion about the long-anticipated market surge following the recent decision by the Centers for Medicare and Medicaid Services (CMS) to unbundle reimbursement for certain diagnostic radiopharmaceuticals.

I. RECENT COMMERCIAL Developments (CDMO/CMO/Radiopharmacy)

a. Operating Model Expansions

• Jubilant Radiopharma and Simplified Imaging Solutions (SIS), a diagnostic services organization (DSO), announced a strategic partnership aimed at enhancing the operational efficiencies of nuclear medicine services. This strategic partnership combines the national network of 43 single photon emission computed tomography (SPECT) radiopharmacies and three positron emission tomography (PET) manufacturing facilities of Jubilant with the fixed and mobile diagnostic solutions of SIS. This may be the first of its kind comprehensive full-service nuclear medicine solution that combines a national network of radiopharmacies with a DSO.
• Following the regulatory approval and launch of the world’s first commercial module for manufacturing of Astatine-211 (At-211) radiopharmaceuticals, Minerva Imaging announced that Atley Solutions had delivered and installed the first commercial unit at Minerva’s facilities in Denmark. The delivery of the Atley C100 marks a significant technical and commercial milestone for Atley Solutions and strengthens the company’s position as a global leader in commercial products and services for At-211 radiopharmaceuticals. Further, it strengthens both companies’ ability to offer research, development and manufacturing services.
• Sofie Biosciences announced the opening of a new radiopharmaceutical production and research facility in Decatur, Illinois. This site activation strengthens Sofie’s production and distribution network, allowing the company to expand its service across Illinois, Missouri and Indiana. Patient dose delivery will begin this week.
• PharmaLogic Holdings announced the official opening of new radiopharmaceutical production and research facilities in Los Angeles and Salt Lake City. These developments represent a major step forward in PharmaLogic’s mission to deliver radiopharmaceuticals to patients across North America.
• Ionetix announced the official start of the project to expand its alpha isotope manufacturing facility in Lansing, Michigan. The expansion project will add over 5,000 square feet of additional space to the existing building. The new addition will house a second cyclotron and additional isotope processing lab equipment and infrastructure. The new cyclotron will have dual target stations and utilize Ionetix’s proprietary cyclotron target technology for actinium-225 (Ac-225) production.

b. Collaborations and Manufacturing Capabilities

• Cardinal Health announced the start of weekly production of Ac-225 through its Center for Theranostics Advancement in Indianapolis in collaboration with TerraPower Isotopes.
• NorthStar Medical Radioisotopes and YAP Therapeutics entered into a collaboration agreement involving NorthStar suppling the radioisotope noncarrier added Ac-225 and providing CDMO services, including clinical trial support and potentially commercial supply upon any product approval.
• United Theranostics, a provider of radiopharmaceutical therapy and supportive molecular imaging for cancer treatment, closed a $15 million senior debt facility with Old National Bank. The company will use proceeds from the facility to fund the expansion of its nationwide network of clinics offering patient-approved radiopharmaceutical therapies and clinical trials for new radiopharmaceutical drugs under investigation.
• Eckert & Ziegler entered into a global supply agreement with GlyTherix for Ac-225. Under the agreement, Eckert & Ziegler will provide Ac-225 to support GlyTherix’s clinical research and development activities on innovative alpha radiotherapeutics.
• Eckert & Ziegler and Ariceum Therapeutics signed a global supply agreement for the medical radionuclides Ac-225 and Lutetium-177 (Lu-177).
• AtomVie Global Radiopharma entered into an agreement with Radiopharm Ventures, a joint venture between Radiopharm Theranostics and MD Anderson Cancer Center, to develop and manufacture 177 Lu-BetaBart, a 177 Lutetium-conjugated B7-H3 targeting radioantibody.
• Nucleus Radiopharma and Clarity Pharmaceuticals entered into a clinical manufacturing agreement involving Nucleus supplying ⁶⁷Cu-SAR-bisPSMA. Nucleus RadioPharma’s facility in Minnesota enables ⁶⁷Cu-SAR-bisPSMA manufacturing and distribution to all 50 states.
• Sofie Biosciences expanded its 18F-FAPI-74 production at sites in New Jersey, California, Illinois and Florida with additional expansion planned for 2025.
• Plus Therapeutics and SpectronRx signed a manufacturing agreement for the production of Rhenium (186Re) Obisbemeda, a radiotherapy for central nervous system cancers, including leptomeningeal metastases and recurrent glioblastoma.
• Siemens Healthineers has entered into a technology licensing agreement with Kromek Group to enable the in-house production of cadmium zinc telluride (CZT) material for gamma ray detectors used in SPECT systems. Under the terms of the agreement, Siemens Healthineers will license the technology to produce CZT, which will extend its research, development and manufacturing capabilities to allow for a potential future line of gamma ray detectors for multimodal SPECT systems.

c. New Acquisitions

• GE HealthCare agreed to acquire full ownership of Nihon Medi-Physics (NMP) by purchasing from Sumitomo Chemical the 50% stake it does not already own. As part of GE HealthCare, NMP will build on its expertise developing and manufacturing proprietary and in-licensed radiopharmaceuticals used SPECT and PET molecular imaging procedures.
• Lantheus Holdings entered into a definitive agreement to acquire Evergreen Theragnostics in an all-cash transaction consisting of an upfront payment of $250 million and up to an additional $752.5 million in potential milestone payments. The company also entered into a definitive agreement to acquire Life Molecular Imaging in an all-cash transaction consisting of an upfront payment of $350 million and up to an additional $400 million in potential earn-out and milestone payments. Lantheus also became the largest shareholder of Radiopharm Theranostics by executing a private placement of $5 million and increasing its stake to 12.16% of the company.
• Telix Pharmaceuticals completed the acquisition of the antibody engineering company ImaginAb. Telix has acquired a pipeline of next-generation therapeutic candidates, a proprietary novel biologics technology platform, and a protein engineering and discovery research facility to enhance existing innovation capabilities. Telix acquired these assets through an asset purchase agreement with a concurrent technology license agreement. The purchase price for the transaction is $45 million. The transaction adds a state-of-the-art research facility in Los Angeles to Telix’s U.S. operations.
• BWX Technologies entered into an agreement to acquire Kinectrics for approximately $525 million, including assumption of Kinectrics’ net pension and debt liabilities and estimated transaction expenses. Kinectrics is a leader in providing lifecycle management services for the global nuclear power and transmission and distribution markets and in the production and supply of isotopes for the radiopharmaceutical industry.
• Thermo Fisher Scientific entered into a definitive agreement with Solventum to acquire Solventum’s Purification & Filtration business for approximately $4.1 billion in cash. Solventum’s Purification & Filtration business is a leading provider of purification and filtration technologies used in the production of biologics, medical technologies and industrial applications.

d.  New or Increased Investments

• AdvanCell announced the successful completion of an oversubscribed $112 million Series C financing. This milestone funding round was co-led by SV Health Investors, Sanofi Ventures, Abingworth and SymBiosis. Additional support came from existing investor Morningside alongside new investors Tenmile, Brandon Capital and others.
• ROTOP Pharmaka GmbH (ROTOP) announced new investments from GENUI & SHS Capital to help expand its footprint in various markets.

e. Leadership Changes

• Ephicacy Consulting Group, a biometrics CRO, appointed Tara Gladwell as chief executive officer. Gladwell joins Ephicacy from Rho, a global CRO where she served as president and led the company’s growth strategy.
• ROTOP Pharmaka GmbH (ROTOP) announced the appointment of Andrew Varghese as president of ROTOP USA. Varghese served at GE Healthcare for 16 years, and his roles spanned from research, product development and product management to leading various global teams. Varghese led GE Healthcare’s Osteoporosis and Metabolic Health product and service business.

f. Other

• The Society of Nuclear Medicine and Molecular Imaging has launched an Emerging Technologies and Radiopharmaceuticals Task Force, replacing the former PET/MRI Task Force, to encompass a wider range of technologies and radiopharmaceuticals in nuclear medicine. Its primary mission is to identify emerging technologies, assess their intersection with nuclear medicine, and engage and educate technologists to promote wider adoption.

II. U.S. Regulatory Developments

a. Reimbursement

On Nov. 24, 2024, CMS finalized a rule that significantly changed the reimbursement for diagnostic radiopharmaceutical products (89 FR 93912). Prior to the new rule, CMS had packaged diagnostic radiopharmaceuticals with their associated diagnostic test, as these drugs were considered supplies needed for the test. This reimbursement strategy resulted in a cost deficit for many of these drugs, because the reimbursement rate for the diagnostic test did not cover the cost of the radiopharmaceutical component. The reimbursement also created a barrier for many Medicare beneficiaries because hospitals and providers were unwilling to offer services including more expensive diagnostic radiopharmaceuticals at a loss.

Further, this reimbursement policy impacted clinical research, particularly in the Alzheimer’s disease space. As CMS noted in the new final rule, commentors reported difficulties in enrolling many hospitals in clinical studies for Alzheimer’s disease, stifling research of a widely prevalent condition impacting millions of older Americans.

In the final rule, CMS updated its reimbursement strategy for diagnostic radiopharmaceuticals. Rather than packaging all radiopharmaceuticals with their associated diagnostic tests, the agency set a threshold limit of $630 per day costs, above which the agency would unpackage and reimburse the drug separately from the diagnostic test. Under the final rule, payment for qualifying radiopharmaceuticals will be based on the mean unit cost (MUC) of each product in a given year. This MUC pricing will remain until CMS can transition to basing reimbursement on the average sales price (ASP). CMS believes the use of ASP information for outpatient prospective payment systems (OPPS) payment could provide an opportunity to improve payment accuracy for separately payable diagnostic radiopharmaceuticals by applying an established methodology that has already been successfully implemented under the OPPS for other separately payable drugs and biologicals, as well as therapeutic radiopharmaceuticals. Before adopting ASP, CMS has indicated that more consistent, validated and universal reporting would be necessary to create the ASP data that can support a viable payment methodology.

Most stakeholders support the rule, which went into effect Jan. 1, 2025. Not only will this reimbursement update increase access to existing radiopharmaceuticals and cutting-edge technologies but it could foster innovation to continue to develop these types of drugs, knowing that reimbursement will be available after the initial pass-through status of the drug expires. Starting in 2026 and subsequent years, CMS intends to update the proposed threshold amount of $630 by the producer price index (PPI) for Pharmaceuticals for Human Use (Prescription) (Bureau of Labor Statistics series code WPUSI07003) from IHS Global.

In the same rule, CMS finalized its proposal to establish an add-on payment of $10 per dose for radiopharmaceuticals that use technetium-99m (Tc-99m) derived from domestically produced molybdenum-99 (Mo-99), beginning Jan. 1, 2026.

b. OIG Updated Opinion

On Feb. 7, 2025, the Office of the Inspector General (OIG) issued an update to Advisory Opinion No. 21-13, issued on Sept. 29, 2021, (the 2021 opinion). The opinion supported the continued enforcement discretion against a clinical trial sponsor for federal antikickback and beneficiary inducements civil monetary penalties for the subsidizing of coinsurance for a clinical trial in Medicare beneficiaries receiving a PET scan for the detection of Alzheimer’s disease. The update was issued in response to the change in reimbursement of positron emission tomography scans for beta amyloid (PET Aβ), a protein associated with Alzheimer’s disease.

The 2021 opinion evaluated the proposal by the requesters of the opinion to provide coverage of the coinsurance costs for a PET Aβ in a clinical study evaluating patient outcomes in a diverse population of Medicare beneficiaries with cognitive impairment. At the time the opinion was issued, PET Aβ scans were covered through Coverage with Evidence Development (CED), which permitted coverage of a single PET Aβ scan in the Medicare beneficiary’s lifetime, with a coinsurance fee. The clinical study sought to fill a data gap in Alzheimer’s disease research for Hispanic and African American patients, who are understudied despite carrying a higher risk for the disease. The requirement of the coinsurance was seen as a potential barrier to enrollment for potential subjects in the study. The directors did not advertise that the insurance was to be covered, but informed potential subjects during the informed consent process that it would be provided. OIG found that the study activities would trigger the federal anti-kickback provisions because the coinsurance subsidy could induce Medicare beneficiaries to join the study and receive the PET Aβ that they would not normally receive and trigger the beneficiary inducements civil money penalty because the subsidy would induce the subject to receive the treatment from a particular provider that was to be involved in the study. But OIG exercised enforcement discretion, as these activities were not the types of activities typically involved in seeding arrangements, nor were inappropriate or considered overuse of a federal health benefit.

Since the 2021 opinion was issued, the development and acceptance of Alzheimer’s disease therapies and PET Aβ imaging has progressed rapidly. The limitation of a single PET Aβ was inconsistent with research trends and treatment paradigms seeking to establish disease progression following administration of investigational and approved treatments. CMS reviewed the coverage determination for the PET Aβ and, in October 2023, ended the coverage through CED and shifted to coverage decisions as determined by the Medicare Administrative Contractors (MACs). The use of MACs would allow for additional PET Aβ to be completed if the MAC determined the PET Aβ use to be appropriate, including a review of the available evidence when making a coverage decision.

With the shift in coverage by CMS, the initial requesters of the 2021 opinion requested that OIG modify the opinion to include the new coverage by MACs. Though CMS found the same triggers to the federal antikickback and beneficiary inducements civil money penalties, they reaffirmed their opinion of enforcement discretion, as the new coverage paradigm did not change the rationale provided in the 2021 opinion.

While OIG opinions are limited to the circumstances specified in the opinion, the implications of the updated opinion on research and development of radiopharmaceuticals are substantial. Removing barriers to research that could lead to earlier and more accurate diagnoses is critical in advancing new therapies and potential cures that will benefit not only Medicare beneficiaries, but the aging population as a whole.

c. Transportation: Type A vs. Type B Packaging

The transport of radiopharmaceuticals is regulated internationally by the International Atomic Energy Agency (IAEA) under their guidelines titled “IAEA Specific Safety Requirements No. SSR-6, Regulations for the Safe Transport of Radioactive Material” (SSR-6). In the U.S., this activity is supported by the Department of Transportation and the Nuclear Regulatory Commission (NRC). Radiopharmaceuticals are shipped in one of two packaging types, Type A (excepted) and Type B, which have been designed to prevent accidental release or exposure. The type of packaging used is dependent on the quantity of radioactive material to be transported. Type B packaging is intended for larger quantity of radioactive materials and requires certification by the NRC, as detailed in 10 CFR Part 71. Typically, radiopharmaceuticals are transported in Type A packages.

The limitations on the amount of radioactive material that can be included in a Type A package are dictated in part by two values, A₁ and A₂, established by the IAEA. The A₁ value is the activity of a special form radioactive material and A₂ is the activity value of radioactive material other than special form radioactive material, which can be included in a Type A package. These values are based on the Q-system radiological model, which evaluates the quantity of exposure from five different scenarios, including exposure to the skin, exposure from inhalation, exposure from external gamma radiation, exposure from external beta radiation, and exposure from submersion due to gaseous isotopes. The IAEA Working Group on A₁/A₂ has proposed revisions to how these values are calculated, and the result was significantly lower permissible A₁ and A₂ values for Type A packaging.

Members of the radiopharmaceutical industry are displeased with the new proposed A₁ and A₂ values and have expressed concern that the increased restrictions would lead to substantial supply chain issues for radiopharmaceuticals. The Council on Radionuclides and Radiopharmaceuticals (CORAR), which represents industry members of the radionuclide and radiopharmaceutical field, has released a position paper that describes the potential threats to the industry as a result of the new proposed restrictions. CORAR is concerned that the growing field of Targeted Alpha Therapy (TAT), a new area of research for treatment for certain cancers, could be threatened by the new restrictions. TAT products are in limited supply given the manufacturing and transport challenges associated with the products. The change in the proposed A₁ and A₂ values would require TAT products to be transported in Type B packaging, which is more expensive, is limited in supply and requires special procedures for shipping and receiving. CORAR notes that other therapies could similarly be impacted, as these products require frequent shipping due to short half-lives and manufacturing challenges. In its comments to the March 11, 2024, Federal Register notice seeking public input on the proposed changes (89 FR 17537), CORAR also notes that many radiopharmaceuticals are already in short supply, with use expected to increase as the support for the therapy grows. Cardinal Health supported CORAR’s comments through a submission of its own and added that it agrees with CORAR that the new proposed A₁ and A₂ values are overly conservative and will lead to increased logistical challenges and costs to the U.S. healthcare environment.

The final version of the revised SSR-6 has not been released and was originally targeted for a January 2026 release date. Industry members should carefully monitor any further communications from the IAEA, including comments addressing the concerns of the member states.

III. Conclusion

The radiopharmaceutical industry stands at a pivotal moment as it transitions through Q1 2025, propelled by robust market growth projections, innovative commercial developments and evolving regulatory frameworks. The strategic partnerships, facility expansions and collaborations outlined in this update — such as Jubilant Radiopharma’s alliance with Simplified Imaging Solutions, Sofie and PharmaLogic’s new facilities, and NorthStar’s agreement with YAP Therapeutics — underscore a sector responding dynamically to rising demand for diagnostic and therapeutic radiopharmaceuticals. These efforts are bolstered by significant investments and acquisitions, such as Lantheus Holdings’ purchase of Evergreen Theragnostics and Telix’s acquisition of ImaginAb, which enhance manufacturing capabilities and innovation pipelines critical to addressing supply chain bottlenecks and advancing theranostics.

Regulatory shifts, particularly CMS’s decision to unbundle reimbursement for diagnostic radiopharmaceuticals, signal a more supportive environment for access and research, especially for aging populations and underserved communities. However, challenges loom, notably with the IAEA’s proposed A₁/A₂ value revisions for Type A packaging, which could disrupt the supply chain in the coming years if not addressed thoughtfully. As the industry navigates these opportunities and hurdles, continued collaboration between CDMOs, radiopharmacies, regulators and industry advocates will be essential to sustain momentum, ensure patient access and capitalize on the projected market surge. With North America poised to lead a global market potentially exceeding $40 billion by the early 2030s, the radiopharmaceutical sector is well-positioned for transformative growth — provided it can adapt to both its promise and its complexities.